Product registration for invasive blood pressure monitors may require clinical trials and need to follow specific guidelines and regulations. Here are some guidelines that may apply to clinical trials of invasive blood pressure monitors:
The ISO 81060 series of standards covers different types of blood pressure monitoring devices and provides general guidance for clinical trials, including:
iso 81060-2：This criterion focuses on the clinical evaluation of non-invasive blood pressure measurements. It provides general guidance for clinical trials of invasive blood pressure monitors, covering aspects such as trial design, data collection, analysis, and reporting.
FDA (Food and Drug Administration):The FDA's medical device registration process typically requires clinical trials. Guidelines for clinical trials can be found on the FDA's **, such as the Clinical Trial Guidelines and the Medical Device Registration Guidelines.
EU CE marking:The EU has detailed guidelines and requirements for the registration of medical devices, involving clinical evaluation, clinical trials, etc. CE marking requires compliance with the Medical Device Directive (MDD) or Medical Device Regulation (MDR).
China NMPA (National Medical Products Administration):The NMPA's guidance for the registration of medical devices may include provisions and requirements for clinical trials.
International Journals and Professional Organizations:Some medical journals, clinical research institutes, and professional medical organizations may have published guidelines and best practices regarding clinical trials of blood pressure monitoring devices.
When conducting clinical trials of invasive blood pressure monitors, it is necessary to follow the regulations and guidelines of the relevant countries and regions to ensure the legitimacy and reliability of the trial. It is best to consult with a professional clinical researcher, regulatory expert, or agency with experience in clinical trials to get the right guidance.